Twenty-three of 26 patients achieved a partial response or stable disease in the phase II, said Jung-Min Lee, MD, a fellow at the National Cancer Institute in Bethesda, Md., at the annual meeting of the American Society of Clinical Oncology.

The median duration of [response in] the six patients who achieved partial responses was 18.9 months, while the median duration for the 23 patients who achieved stable disease was about six months, Lee told MedPage Today.

Among patients diagnosed with epithelial ovarian cancer who had not previously been treated with bevacizumab, "the combination of sorafenib and bevacizumab yields promising clinical benefits with manageable toxicity," Lee said.

The most serious adverse events were increases in hypertension, with 47% of the patients experiencing grade 2-4 hypertension, she reported. About 13% of patients experienced grade 3 thrombosis.

However manageable these adverse events were, they may rule out the combination as routine treatment for these patients, suggested Michael Birrer, MD, PhD, from Massachusetts General Hospital/Harvard Medical School in Boston.

"That is a lot of hypertension," Birrer told MedPage Today. "There may be better combinations of biologic agents." He suggested that sorafenib, which attacks a number of molecular targets, could be replaced by a more focused medicine. "It is the off-target activities of the drugs that cause the adverse events," he said.

In the study, Lee and colleagues enrolled patients who had either been treated with bevacizumab or were naïve to treatment. She reported the results of those patients naïve to bevacizumab.

Adult women diagnosed with recurrent epithelial ovarian, fallopian, or peritoneal cancer were enrolled if they met the following criteria within a four to six week period prior to the study getting underway:

No surgery

No radiation therapy

No chemotherapy

No immunotherapy, biotherapy, or hormonal therapy aside from raloxifene for bone health

Good organ function

An Eastern Cooperative Oncology Group performance status 0 or 1

Patients were treated with sorafenib 200 mg twice a day on days 1-5 every week, and were also treated with 5 mg of bevacizumab every two weeks. Emollients were also given to protect and treat hand-foot syndrome.

All the women in the interim report were diagnosed with serous ovarian cancer. Lee reported that the average age of the 30 women who were evaluable for the study was 51 years; two of the women were performance status 0, and the rest were performance status 1. Four women had undergone prior hormonal therapy; four had been treated with previous immunotherapy. Six of the women had undergone previous chemotherapy, and all these patients had cancers that were resistant to platinum-based therapy.

The only grade 4 adverse event was one case of hypertension. One women experienced grade 3 hand-foot syndrome, while 13 experienced grade 3 hypertension, and two women had grade 3 elevated liver enzymes. One patient had a grade 3 anal fissure and one woman had a grade 3 headache.

"Most of the grade 3-4 toxicities occurred early and were manageable," Lee said. "Patients who required anti-hypertensive therapy were weaned upon completion of treatment with no adverse events."

The researchers reported on outcomes of 26 of the women: Three of the women had disease progression, but a clinical benefit was achieved by 88% of the patients, she said.

"Most patients reduced sorafenib to 200 mg daily within the first two cycles without loss of clinical benefit," Lee said. "Combined with bevacizumab, this is a highly tolerable combination."

None of the authors had any relevant disclosures. Birrer had no disclosures.

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